The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom (UK) issued a medical device alert concerning HeartStart XL defibrillator/monitor with M3516A batteries of lot number with 'LK' prefix manufactured by Philips Healthcare.

TheAccording to the MHRA, defibrillator battery life has been reduced from 1.5 years to 1 year and the capacity test interval has been reduced from six months to three months. This applies to new batteries with the lot number prefix 'LK'.

The MHRA clarifies that Philips HeartStart XL batteries with lot code prefixes 'P', 'R', and 'PCS' are not affected by this change and continue to have a life expectancy of about 1.5 years, when properly maintained and stored, and battery capacity test intervals of 6 months (for infrequent use) or 3 months (for frequent use). These batteries are still supported with relevant instructions for use and labelling.

Philips is supplying an addendum (see appendix of the alert) with battery orders and HeartStart XL monitor/defibrillator orders stating the changes to HeartStart XL instructions for use (edition 7) and HeartStart XL service manual (edition 6).

The MHRA provides the following advice to the affected users:

• Ensure all relevant staff are aware of the changes.
• Ensure that the addendum is attached to the instructions for use and service manuals accordingly.
• Be aware that this addendum supersedes any previous guidance given by Philips regarding battery life and capacity test frequency.

For details, please visit the following MHRA website:
http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON305480

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 16 August 2013